JP6735427B2 - Delivery device and delivery method for leadless heart device - Google Patents

Description

The present disclosure relates to medical devices and methods of making and/or using medical devices. In particular, the present disclosure relates to leadless cardiac devices and methods, such as leadless pacing devices and methods, and delivery devices and methods for such leadless devices.

Various medical devices have been developed as devices used for medical applications such as the heart. These devices include devices such as catheters, leads and pacemakers, and delivery devices and/or systems used to deliver such devices. These devices may be manufactured by any one of a variety of different manufacturing methods and used in accordance with any one of a variety of methods. Known medical devices, delivery systems and methods each have advantages and disadvantages. There is a continuing need to provide yet another medical device and delivery device, and yet another method for making and using the medical device and delivery device.

It is an object of the present disclosure to provide medical device and delivery device designs, materials, manufacturing methods and use options.

In one example of the present disclosure, a delivery device for delivering an implantable leadless pacing device is an outer tubular member having an outer tubular member lumen extending from a proximal end to a distal end thereof. And an intermediate tubular member coaxially and slidably disposed within the outer tubular member lumen. The intermediate tubular member has an intermediate tubular member lumen extending from its proximal end to its distal end. The inner tubular member is disposed within the inner tubular member lumen, coaxially and slidably with the intermediate tubular member lumen, and has an inner tubular member lumen extending from a proximal end to a distal end of the inner tubular member. ing. A distal holding portion extends distally from the distal end of the intermediate tubular member, and a space for receiving the implantable leadless pacing device extends inside the distal holding portion. The placement funnel is fixed to the tip of the inner tubular member, and the placement funnel is seated in the forward end position where the placement funnel extends toward the tip side in the tip-side holding portion and the placement funnel is seated in the base end portion of the tip-side holding portion. It is movable to and from the retracted position. The placement funnel is configured to allow fluid flow from the tip of the lumen of the intermediate tubular member to the distal retainer when the placement funnel is in the retracted position.

Alternatively or in addition to any of the above embodiments, the deployment funnel has one or more openings extending therethrough and in communication with the intermediate tubular member lumen, This allows fluid to flow from the tip of the lumen of the intermediate tubular member through the one or more openings into the tip-side retainer.

Alternatively or in addition to any of the above embodiments, the deployment funnel has one or more channels in communication with the intermediate tubular member lumen, whereby the distal end of the intermediate tubular member lumen. Fluid is allowed to flow into the distal holding portion from the through one or more grooves.

Alternatively or in addition to any of the above embodiments, at least a portion of the deployment funnel comprises a porous material, allowing fluid to flow through the pores of the porous material.
Alternatively or in addition to any of the above embodiments, at least a portion of the deployment funnel includes scaffolding material to allow fluid to flow through the gaps in the scaffolding material.

Alternatively or in addition to any of the above embodiments, the deployment funnel is further configured to provide a fluid coupling between the inner tubular member lumen and the distal retainer when the deployment funnel is in the retracted position. ing.

Alternatively or in addition to any of the above embodiments, the deployment funnel has a central opening that is aligned with the inner tubular member lumen.
Alternatively or in addition to any of the above embodiments, the inner tubular member lumen extends proximally to the fluid port.

Alternatively or in addition to any of the above embodiments, the intermediate tubular member lumen extends proximally to the fluid port.
In another example of the present disclosure, a delivery device for delivering an implantable leadless pacing device is an outer tubular member that defines an outer tubular member lumen extending from a proximal end to a distal end thereof. A tubular member and an intermediate tubular member movably disposed within the outer tubular member lumen. The intermediate tubular member defines an intermediate tubular member lumen extending from its proximal end to its distal end. The distal retention portion extends from the distal end of the intermediate tubular member and is configured to at least partially receive the implantable leadless pacing device within the distal retention portion. The intermediate tubular member has a retracted position in which the proximal end portion of the distal-side holding portion is seated inside the outer tubular member lumen, and the proximal end portion of the distal-side holding portion extends from the outer tubular member lumen toward the distal side. It is movable to and from the extended position. The inner tubular member is movably disposed within the inner tubular member lumen and defines an inner tubular member lumen extending from a proximal end to a distal end of the inner tubular member. The deployment funnel is fixed to the tip of the inner tubular member. The inner tubular member is moveable between an expanded position in which the placement funnel extends distally within the distal side retainer and a retracted position in which the placement funnel is seated within the proximal end of the distal side retainer. The placement funnel is configured to allow fluid to flow from the tip of the lumen of the intermediate tubular member into the distal holding portion when in the retracted position.

Alternatively or in addition to any of the above embodiments, the placement funnel has one or more openings through the placement funnel to allow fluid to flow past the placement funnel in the retracted position. Have a section.

Alternatively or in addition to any of the above embodiments, the placement funnel has one or more grooves in the surface of the placement funnel to allow fluid to flow past the placement funnel in the retracted position. doing.

Alternatively or in addition to any of the above embodiments, at least a portion of the deployment funnel comprises a porous material, allowing fluid to flow through the pores of the porous material.
Alternatively or in addition to any of the above embodiments, the outer tubular member lumen is proximal to the fluid port so that fluid can flush the outer tubular member lumen when the intermediate tubular member is in the retracted position. Extends to.

Alternatively or in addition to any of the above embodiments, the intermediate tubular member lumen may be up to a fluid port so that the fluid may flush the intermediate tubular member lumen regardless of the position of the inner tubular member relative to the intermediate tubular member. It extends in the proximal direction.

Alternatively or in addition to any of the above embodiments, the inner tubular member has an opening proximal to the distal end of the inner tubular member that allows the inner tubular member lumen and the inner tubular member to be opened. A fluid path is formed with the member lumen whereby fluid enters the inner tubular member lumen from the intermediate tubular member lumen and flows distally through the placement funnel into the distal retainer. It is possible to do.

Instead of or in addition to any of the above embodiments, the intermediate tubular member has an opening at the proximal end side of the distal end of the intermediate tubular member, by which opening the outer tubular member lumen and the intermediate tubular member are provided. A fluid path is formed with the member lumen that allows fluid to enter the outer tubular member lumen, the intermediate tubular member lumen, and flow distally through the placement funnel into the distal retainer. It is possible to do.

In another example of the present disclosure, a delivery system for delivering a leadless cardiac pacemaker (LCP) includes a flexure shaft defining a flexure shaft lumen and extending through the flexure shaft lumen, and And an expansion shaft forming an expansion shaft lumen. A leadless cardiac pacemaker sleeve is secured to and extends distally from the distal end of the dilation shaft and is configured to at least partially contain the leadless cardiac pacemaker for delivery. The deployment shaft extends through the expansion shaft lumen to form a deployment shaft lumen. The deployment funnel is secured to the tip of the deployment shaft and leads to hold the leadless cardiac pacemaker in place when the leadless cardiac pacemaker sleeve is pulled back proximally to the leadless cardiac pacemaker. Configured to engage a less cardiac pacemaker. The deployment funnel is configured to extend within the deployment shaft lumen to accommodate a tether passing through a central opening of the deployment funnel, the central opening aligned with the deployment shaft lumen, and the deployment funnel , Has one or more fluid structures that allow fluid to flow distally from the expansion shaft lumen, past the deployment funnel, and into the leadless cardiac pacemaker sleeve.

Alternatively or in addition to any of the above embodiments, the delivery system further comprises a handle assembly configured to control the position of the deployment shaft relative to the expansion shaft and/or the position of the expansion shaft relative to the flexure shaft. ing.

Alternatively or in addition to any of the above embodiments, the handle assembly has a first fluid port fluidly coupled to the flexure shaft lumen.
Alternatively or in addition to any of the above embodiments, the handle assembly has a second fluid port that is fluidly coupled to the expansion shaft lumen.

Alternatively or in addition to any of the above embodiments, the handle assembly has a third fluid port that is fluidly coupled to the deployment shaft lumen.
Alternatively or in addition to any of the above embodiments, a deployment funnel may have one or more on the surface of the deployment funnel to allow fluid to flow past the deployment funnel and into the leadless cardiac pacemaker sleeve. It has a plurality of grooves.

Alternatively or in addition to any of the above embodiments, one or more grooves are formed in the radially outer surface of the deployment funnel that seats in the hub portion of the leadless cardiac pacemaker sleeve.

Alternatively or in addition to any of the above embodiments, one or more grooves are formed in the radially inner surface of the deployment funnel that seats in the head portion of the docking member of a leadless cardiac pacemaker.

Alternatively or in addition to any of the above embodiments, the deployment shaft has an opening extending through the side wall that provides a connection between the expansion shaft lumen and the deployment shaft lumen. A fluid path is formed therebetween that allows fluid to enter from the expansion shaft lumen into the deployment shaft lumen, flow distally through the deployment funnel, and into the leadless cardiac pacemaker sleeve. Has become.

The above summary of some exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. Some of these embodiments are illustrated in detail by the following figures and detailed description.

The present disclosure is fully understood by considering the following detailed description with reference to the accompanying drawings.

FIG. 6 is a plan view of an exemplary leadless pacing device implanted within the heart. FIG. 3 is a side view of an exemplary implantable leadless cardiac pacing device. FIG. 6 is a top view of an exemplary delivery device for an implantable leadless cardiac pacing device. FIG. 4 is a side sectional view showing a part of the distal end portion of the delivery device in FIG. 3. FIG. 4 is a top view showing the handle of the exemplary delivery device of FIG. 3. FIG. 4 is a bottom view showing the handle of the exemplary delivery device of FIG. 3. FIG. 4 is an enlarged cross-sectional view of a portion of the exemplary delivery device of FIG. 3 showing fluid pathways within the delivery device. FIG. 4 is an enlarged cross-sectional view of a portion of the exemplary delivery device of FIG. 3 showing fluid pathways within the delivery device. FIG. 4 is an end view showing a deployment funnel usable as part of the delivery device of FIG. 3. 9B is a cross-sectional view of the placement funnel of FIG. 9A taken along line 9B-9B. FIG. 3 is an enlarged cross-sectional view of a portion of an exemplary delivery device showing fluid pathways within the delivery device. FIG. 11 is an end view showing a deployment funnel usable as part of the delivery device of FIG. 10. FIG. 11B is a perspective view of the placement funnel of FIG. 11A. FIG. 11 is a perspective view of another deployment funnel usable as part of the delivery device of FIG. 10. FIG. 11C is an end view showing the placement funnel of FIG. 11C. FIG. 11C is a perspective view of the deployment funnel of FIG. 11C engaged with an implantable device. FIG. 3 is an enlarged cross-sectional view of a portion of an exemplary delivery device showing fluid pathways within the delivery device. 13 is a plan view showing a deployment funnel that can be used as part of the delivery device of FIGS. FIG. 13 is a plan view showing a deployment funnel and inner tubular member that can be used as part of the delivery device of FIGS.

While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. However, the invention is not limited to the particular embodiments described. The invention also includes all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

For the terms defined below, the following definitions shall apply, unless another definition is given in the claims or the specification.
All numeric values are herein assumed to be modified by the term "about," whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (ie, having the same function or result). In many cases, the word "about" will have the number rounded to the nearest significant number.

The recitation of numerical ranges by upper and lower limits includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4 and 5). ).
In this specification and the appended claims, the singular "a" and "the" include plural objects unless the context clearly dictates otherwise. In this specification and the appended claims, the term "or" is intended to include the meaning "and/or" unless stated otherwise.

In this specification, references to "one embodiment," "some embodiments," "other embodiments," etc. refer to particular features, structures, and/or one or more of the described embodiments. It has a characteristic. However, the descriptions do not necessarily mean that all embodiments include particular features, structures, and/or characteristics. Also, the particular features, structures and/or characteristics described in connection with one embodiment apply with other embodiments whether or not explicitly described, unless explicitly stated to the contrary. It is possible.

In the following detailed description, reference will be made to the figures, where like components in different figures are numbered the same. The drawings are not necessarily to scale and represent exemplary embodiments and are not intended to limit the scope of the present disclosure.

Cardiac pacemakers electrically stimulate heart tissue to contract the heart and pump blood into the vasculature. Typical conventional pacemakers have electrical leads that extend from a pulse generator that is implanted subcutaneously or submuscularly to electrodes that are located adjacent the inner or outer wall of the heart chamber. As an alternative to conventional pacemakers, integrated or leadless cardiac pacemakers have been proposed. Leadless cardiac pacemakers are generally small capsules that are fixed at the site of cardiac implantation within the heart chamber. A typical miniature capsule has a bipolar pacing/sensing electrode, a power supply (eg, a battery) and associated electrical circuitry to control the pacing/sensing electrode to provide electrical stimulation to cardiac tissue and/or physiological conditions. Sense of. The capsule can be delivered to the heart using a delivery device. The delivery device enters the inferior vena cava through the femoral vein and into the right ventricle through the right atrium and tricuspid valve. Therefore, it is desirable to provide a delivery device that can be easily advanced through the vasculature.

FIG. 1 illustrates an exemplary implantable leadless cardiac pacing device 10 (eg, leadless pacemaker) implanted within the cavity of the heart H, such as the right ventricle RV. Implantable device 10 is sometimes referred to as a leadless cardiac pacemaker (LCP). FIG. 2 is a side view of an exemplary implantable device 10. Implantable device 10 has an outer shell or housing 12 having a proximal end 14 and a distal end 16. The implantable device 10 includes a first electrode 20 located near the distal end 16 of the housing 12 and a second electrode 22 located near the proximal end 14 of the housing 12. For example, the housing 12 includes a conductive material and is partially insulated in the length direction. The portion along the base end 14 is not insulated to form the second electrode 22. Electrodes 20 and 22 are sensing and/or pacing electrodes that provide electrotherapy and sensing functions. The first electrode 20 is placed in contact with the heart tissue of the heart H, or is placed so as to be able to contact the heart tissue by another method. The second electrode 22 is separated from the first electrode 20 and is separated from the heart tissue.

Implantable device 10 has a pulse generator (such as an electrical circuit) and a power supply (such as a battery) within housing 12 for sending electrical signals to pacing/sensing electrodes 20, 22 to control electrodes 20, 22. .. Electrical communication between the pulse generator and the electrodes 20, 22 allows the application of electrical stimulation to the heart tissue and/or the sensing of physiological conditions.

The implantable device 10 has a fixing mechanism 24 arranged on the proximal side of the distal end 16 of the housing 12. The fixation mechanism 24 is configured to attach the implantable device 10 to a tissue wall of the heart H, or otherwise secure the implantable device 10 to a patient's anatomy. As shown in FIG. 1, in some examples, the fixation mechanism 24 comprises one or more hooks or tines 26 that are fixed to the heart tissue of the heart H for attaching the implantable device 10 to a tissue wall. ing. In other examples, the fixation mechanism 24 may include one or more passive tines configured to entangle with trabeculae within the heart H chambers, or may be screwed into a tissue wall to secure the implantable device 10 to the heart H. And a helical anchor that is configured to

The implantable device 10 has a docking member 30 located on the proximal side of the proximal end 14 of the housing 12. The docking member 30 is configured to facilitate delivery and/or retrieval of the implantable device 10. For example, docking member 30 extends from proximal end 14 of housing 12 along the longitudinal axis of housing 12. The docking member 30 has a head portion 32 and a neck portion 34 extending between the housing 12 and the head portion 32. The head portion 32 is a portion enlarged as compared with the neck portion 34. For example, the radial dimension of head portion 32 from the longitudinal axis of implantable device 10 is greater than the radial dimension of neck portion 34 from the longitudinal axis of implantable device 10. The docking member 30 further includes a tether retaining structure 36 extending from the head portion 32. The tether retaining structure 36 has an opening 38 configured to receive a tether or other fastening mechanism. Although the retention structure 36 is shown to have a "U-shaped" configuration, the retention structure 36 does not allow the tether to be lockably and releasably pierced (looped) through the opening 38. It may have any shape as long as it forms a closed outer peripheral portion around 38. The retention structure 36 extends through the head portion 32 and along the neck portion 34 to the proximal end 14 of the housing 12 or is inserted into the proximal end 14. The docking member 30 is configured to facilitate delivery of, and retrieval from, the intracardiac site of the implantable device 10. The docking member 30 may have other configurations.

One aspect of the present disclosure relates to delivery devices and/or systems used to deliver the device 10 to a suitable location within, for example, an anatomy (eg, heart). The delivery device needs to move through a relatively tortuous anatomy in order to deliver the device 10 in place. For example, in some embodiments, the delivery device is advanced through the vasculature to the target area. In some examples, the device enters the inferior vena cava through the femoral vein and into the right ventricle through the tricuspid valve from within the right atrium. For example, the target area for delivery of device 10 is a site in the right ventricle (such as a site in the right ventricle near the apex). The target region may also be another region of the heart (eg, right atrium, left atrium or left ventricle), blood vessel or other suitable target site. It would be desirable to provide a delivery system with the ability to more easily or properly control movement and delivery.

FIG. 3 is a plan view of an exemplary delivery device 100, such as a catheter, that can be used to deliver implantable device 10. Delivery device 100 includes an outer tubular member 102 having a proximal end 104 and a distal end 106. In some examples, outer tubular member 102 may be considered a flexible shaft. In the outer tubular member lumen 150 (or the flexible shaft lumen) of the outer tubular member 102, the intermediate tubular member 110 is disposed so as to be slidable in the longitudinal direction (see FIG. 4, etc.). The intermediate tubular member 110 can be considered an expansion shaft. An inner tubular member 116 is longitudinally slidably disposed within the intermediate tubular member lumen 152 (or expansion shaft lumen) of the intermediate tubular member 110 (see FIG. 4, etc.). The tip-side holding portion 108 is attached to the tip portion 114 of the intermediate tubular member 110. In some examples, the distal retainer 108 may be considered a leadless cardiac pacemaker sleeve, particularly when configured as an implantable device 10 to accommodate a leadless cardiac pacemaker (LCP). Delivery device 100 also includes a handle assembly 120 disposed proximate proximal end 104 of outer tubular member 102. In some embodiments, the outer diameter D2 of at least a portion of the outer tubular member 102 is smaller than the outer diameter D1 of at least a portion of the retaining portion 108 (see FIG. 4, etc.).

The handle assembly 120 is, for example, fixedly attached to the first or distal hub portion 126, which is, for example, fixedly attached to the proximal end 104 of the outer tubular member 102, and the proximal end of the intermediate tubular member 110. A second hub portion or intermediate hub portion 128 and a third hub portion or proximal hub portion 130 that is, for example, fixedly attached to the proximal end portion of the inner tubular member 116 (FIG. 4). In some examples, inner tubular member 116 may be considered a deployment shaft. The 1st hub part 126, the 2nd hub part 128, and the 3rd hub part 130 have the composition which can be expanded-contracted substantially, and are arranged so that it is slidable to a mutual longitudinal direction. As will be described in more detail below, the first hub portion 126, the second hub portion 128 and the third hub portion 130 allow the outer tubular member 102, the intermediate tubular member 110 and the inner tubular member 116 to be actuated separately. In addition, they can rotate and slide longitudinally with respect to each other. In some examples, it may be desirable to move outer tubular member 102, intermediate tubular member 110 and inner tubular member 116 simultaneously. The handle assembly 120 includes a multi-stage placement mechanism or first locking mechanism 134 that releasably connects the second hub portion 128 to the third hub portion 130. This connection prevents longitudinal relative movement between the second hub portion 128 and the third hub portion 130, resulting in relative longitudinal movement between the intermediate tubular member 110 and the inner tubular member 116. To be prevented. This will be described in detail below. The handle assembly 120 also includes a second locking mechanism 132 that releasably connects the first hub portion 126 to the second hub portion 128. This coupling prevents relative longitudinal movement between the first hub portion 126 and the second hub portion 128, and thus results in relative longitudinal movement between the outer tubular member 102 and the intermediate tubular member 110. To be prevented. This will be described in detail below.

The distal holder 108 is configured to receive the implantable device 10 inside. For example, as shown in FIG. 4, which is a cross-sectional view of the distal end of the delivery device 100, the retainer 108 forms a void 142 that slidably receives the implantable device 10. The retainer 108 also has a distal opening 144 that allows the implantable device 10 to slide into and out of the void 142.

The tip-side holding portion 108 has a main body portion 138 and a tip portion 140 such as a bumper tip configured so as not to damage the anatomy. For example, the tip may contact the anatomy as the catheter moves through the anatomy. Moreover, when delivering a device using a catheter, the tip 140 of the delivery device 100 may come into contact with tissue (eg, cardiac tissue) near the target site. If the tip end is made of the same material as the outer tubular member 102 and the intermediate tubular member 110, it may damage the blood vessel wall or the heart tissue. Therefore, it is desirable to form a softer tip 140 on the delivery device 100 that can be inserted into an anatomy and contact an anatomy in the vicinity of the target site without causing unnecessary trauma.

For example, the tip portion 140 may be made of a softer material than the body portion 138 of the tip side holding portion. In some examples, tip 140 includes a material having a durometer that is less than the durometer of the material of body 138. In some embodiments, the durometer of the material used for tip 140 is in the range of about 5D to about 70D, such as in the range of about 25D to about 65D. Further, the tip 140 may have a shape or structure that does not damage the tissue. For example, the tip-side surface (tissue contacting surface, etc.) of the tip 140 is rounded or has a curved portion configured to further suppress tissue damage.

In some embodiments, the inner surface of all or a portion of the distal retainer 108 is configured to inhibit snagging with one or more hooks or locking mechanisms 24, such as tines 26, of the device 10. .. For example, the tip retainer 108 has an inner layer or coating formed from a harder or smoother material that can resist the force applied to the inner surface of the tip retainer 108 by the securing mechanism 24. For example, the tip-side holding portion 108 may have a multi-layer structure, and the inner layer is made of a material harder than the outer layer.

Inner tubular member 116 is disposed (eg, slidably disposed) within intermediate tubular member lumen 152 of intermediate tubular member 110. The inner tubular member 116 is manipulated by a user at or near the third hub portion 130 and extends through the intermediate tubular member lumen 152 of the intermediate tubular member 110 and into the distal retention portion 108. In some examples, the inner tubular member 116 has a deployment funnel 118 that can engage the device 10, for example, so that the inner tubular member 116 positions the device 10 in a target region (eg, an intracardiac region such as the right ventricle). ) Can be used to “push” the device 10 out of the distal retainer 108 for placement and fixation within. The inner tubular member lumen 154 of the inner tubular member 116 extends from or extends through the deployment funnel 118 from the proximal end 117. The device 10 is releasably secured to the delivery device 100 using a tether 112 or other retention structure. In some examples, the tether 112 is a member having a single or unitary length that extends from the proximal end 117 of the inner tubular member lumen 154 and through the deployment funnel 118 into the opening 38 of the device 10. Through the inner tubular member lumen 154 and back to the proximal end 117 of the inner tubular member 116. Therefore, both ends of the tether 112 are located near the third hub portion 130. In some examples, the end of tether 112 is secured within a locking mechanism within third hub portion 130.

To more accurately position or deliver the delivery device 100 to a location proximate the target site, the delivery device 100 is configured to be deflectable, articulatable, or steerable. With reference to FIG. 3, for example, the outer tubular member 102 and/or the intermediate tubular member 110 may enable deflection, articulation, steering and/or control of the delivery device 100 or a portion thereof in a suitable manner. It may have one or more articulating or flexing mechanisms. For example, the outer tubular member 102 has at least a portion that can be selectively bent and/or deflected in a desired or predetermined direction. This allows the user to orient the delivery device 100 such that the retainer 108 is positioned in a suitable position or orientation to steer or deliver the device 10 to the target site. The outer tubular member 102 may be configured to be able to flex, for example, along a flex area.

Various flexure mechanisms can be used. In some exemplary embodiments, the deflection is provided by one or more actuation members. Examples of actuating members include one or more pull wires extending between the distal end of outer tubular member 102 and actuating mechanism 122 proximate the proximal end of outer tubular member 102. That is, the one or more pull wires extend both proximally and distally of the desired area or location where bending or bending is to occur. As such, the user operates in a suitable manner by actuating (eg, “pulling”) one or more pull wires to apply a compressive and/or flexing force to at least a portion of outer tubular member 102. The outer tubular member 102 can be deflected or bent. Also, in some examples, the one or more wires are rigid enough to exert a pressing or pulling force on outer tubular member 102, such as to position the shaft in a desired position or orientation. It can also be used to "push" or "straighten" the shaft.

In some embodiments, the actuation member is formed as a continuously extending wire and is coupled to the distal region of outer tubular member 102, such as by looping it through the distal region to form a pair of wire portions. doing. However, in another embodiment, the actuation member comprises one or more separate wires that are attached to a metal ring or metal alloy ring, such as near the distal region of outer tubular member 102. There is.

The actuating mechanism 122 has any desired mechanism that allows one or both of tension (ie, pulling force) and compression force (ie, pressing force) to be applied to the actuating member. In some embodiments, the actuation mechanism 122 includes an outer rotating member 124 that is rotatably connected to the handle assembly 120 about the longitudinal axis of the handle assembly 120. The outer rotating member 124 is in threaded engagement with an inner member attached to the proximal end of the actuating member or pull wire. When the outer rotating member 124 is rotated in the first rotation direction, the inner member moves in the first longitudinal direction, whereby tension is applied to the pull wire and a compressive force is applied to the shaft. As a result, the outer tubular member 102 flexes from the initial position to the flexed position. When the outer rotation member 124 is rotated in the second rotation direction, the inner member moves in the second longitudinal direction. This reduces and/or releases the tension on the pull wire, causing the outer tubular member 102 to relax and return to its initial position. In some examples, the one or more wires have sufficient hardness as described above, and the rotation of the outer rotating member 124 in the second rotational direction that moves the inner member in the second longitudinal direction causes the wires to move. A compressive force is exerted on the outer tubular member 102 such that the wire tensions the outer tubular member 102 and pushes the outer tubular member 102 back to an initial position, possibly beyond the initial position and into another position.

The one or more articulating linkages and/or flexures may be such that outer tubular member 102 is provided with a structure or material that causes flexure to a desired degree or position when subjected to compressive or tensile forces. It may be composed of For example, one or more portions of outer tubular member 102 may comprise a structure or material configured to cause the shaft to bend and/or flex in a particular manner when subjected to a predetermined compressive and/or tensile force. ing. For example, the shaft has one or more sections that are more flexible than the other sections, thereby defining areas or locations that provide flexion or articulation. These regions have a plurality of different or varying flexural properties, each of which assumes a particular bent shape when a predetermined force is applied. Such properties are provided by the selection of materials or structures used in different portions of outer tubular member 102.

Other embodiments have other articulating motion mechanisms and/or flexure mechanisms. For example, all or part of delivery device 100, such as outer tubular member 102, may be made of a shape memory material such as a shape memory polymer or shape memory metal. Such materials change or move from the first shape to the second shape when stimulated by the actuation mechanism, such as by temperature change or application of current. Thus, these materials and mechanisms can be used to deflect or bend outer tubular member 102 to a desired condition. Other suitable flexure structures may be used to flex the delivery device 100. Such alternative features may apply to all other and other embodiments illustrated and/or described herein.

Further, one or more predetermined or fixed bends may be provided along the entire length of outer tubular member 102. In some cases, such bends may be configured for a particular anatomy, or may be configured to better move or deliver device 10. Additionally or alternatively, some of the bends described above tend to cause outer tubular member 102 to bend and/or flex in a particular direction or condition when a compressive and/or tensile force is applied to outer tubular member 102. Is configured to be. The outer tubular member 102 may optionally be a laser cut metal tube, a braided reinforced polymer tube or other flexible tubular structure.

Referring again to FIG. 4, the tip-side holding portion 108 is fixed to the tip portion 114 of the intermediate tubular member 110. The tip-side holding portion 108 has a hub portion 136 and a tubular main body portion 138. In some examples, the hub portion 136 is formed of a metal or metal alloy and the body portion 138 is formed of a polymeric material, but it may be other. In some examples, the proximal region 143 of the main body 138 is fixed to the distal end 137 of the hub 136 by thermal bonding or the like. The hub portion 136 has a tapered intermediate region 145 between the base end portion 139 and the tip end portion 137.

In some embodiments, the outer tubular member 102 has a metal ring or tip near the tip 103 for attaching one or more pull wires to the tip 103 of the outer tubular member 102. The outer tubular member 102 may further include a lubricious liner, such as a polytetrafluoroethylene (PTFE) liner. The proximal end 139 of the hub portion 136 extends proximally into the inner lumen 150 of the outer tubular member 102. In some examples, the outer surface of the proximal end 139 forms an interference fit with the inner surface of the outer tubular member 102. The outer surface of the proximal end portion 139 and the inner surface of the outer tubular member 102 may be connected by taper engagement. For example, the distal end 103 of the outer tubular member 102 extends radially outward in the distal direction, and the proximal end portion 139 tapers radially inward in the proximal direction. The two ramps engage when the proximal end 139 is retracted proximally within the outer tubular member 102. Other connection structures may be used if necessary.

When the outer tubular member 102 is bent to move the implantable device 10 to the desired position, the proximal end 139 is advanced distally and disengaged from the inner surface of the outer tubular member 102 and twisted near the coupling region 146. Points or areas of weakness may be formed. The intermediate tubular member 110 is retracted in the proximal direction to bring the intermediate region 145 into contact with the outer tubular member 102 at a contact point 148, or with the proximal end 139 retracted into the outer tubular member 102. By fixing, it is possible to suppress movement of the distal-side holding portion 108 while manipulating the delivery device 100 to a desired position. With such a configuration, tension is applied to the intermediate tubular member 110 while the distal-side holding portion 108 applies a compressive force to the outer tubular member 102. This will be described later. As mentioned above, the locking mechanism 132 of the handle assembly 120 can be utilized to maintain the outer tubular member 102 and the intermediate tubular member 110 releasably in the desired orientation.

5 is a top view of the handle assembly 120 of the delivery device 100, and FIG. 6 is a bottom view of the handle assembly rotated approximately 180 degrees from the state shown in FIG. The handle assembly 120 has one or more ports 158, 160, 162 for delivering fluids such as contrast fluid and irrigation fluid to the void 142 of the distal retention portion 108. The wash ports 158, 160, 162 may be in communication with the lumens 150, 152, 154 of the outer tubular member 102, the intermediate tubular member 110 and the inner tubular member 116, if desired. In some illustrative and non-limiting examples, irrigation port 158 is in communication with outer tubular member lumen 150 of outer tubular member 102 and irrigation port 160 is intermediate tubular member lumen 152 of intermediate tubular member 110. And the irrigation port 162 is in communication with the inner tubular member lumen 154 of the inner tubular member 116.

In some examples, one or more irrigation ports 158, 160, 162 are used to allow air or debris in any of the lumens 150, 152, 154 prior to use of the delivery device 100. Saline or another detergent can be provided to render it absent. In some examples, one or more irrigation ports 158, 160, 162 are used to deliver outer tubular member lumen 150, intermediate tubular member lumen 152 and inner tubular member during delivery and deployment of implantable device 10. A fluid, such as heparinized saline, is continuously supplied to one or more of the lumens 154. This prevents proximal movement of blood or strips through one or more of the lumens 150, 152, 154, such that the strips may clog the delivery device 100, for example. It is suppressed that the operation of 100 is disturbed.

7 and 8 illustrate the fluid paths of the outer tubular member lumen 150, the intermediate tubular member lumen 152, and the inner tubular member lumen 154, respectively, as well as the outer tubular member 102, the intermediate tubular member 110, and the inner tubular member 116. And the effect of this relative movement on the fluid path.

FIG. 7 illustrates outer tubular member 102, intermediate tubular member 110, and inner tubular member 116 with implantable device 10 in place, for example. As described in connection with FIG. 4, the tether 112 extends distally through the inner tubular member lumen 154 and the deployment funnel 118 and is coupled to the tether retaining structure 36. For example, as shown in FIG. 7, the tether 112 extends through the opening 38, around the tether retaining structure 36, and returns proximally through the inner tubular member lumen 154. The tether 112 does not impede fluid flow through the inner tubular member lumen 154. FIG. 8 shows the outer tubular member 102, the intermediate tubular member 110 and the inner tubular member 116 in an axially separated state to show the fluid path. Comparing FIGS. 7 and 8, the inner tubular member 116 is axially movable relative to the intermediate tubular member 110 between an advanced position (FIG. 8) and a retracted position (FIG. 7). I understand. In the forward position (FIG. 8), the placement funnel 118 extends to the tip side and is positioned inside the tip side holding portion 108, or is arranged at a position beyond the tip side holding portion 108 toward the tip side. In the retracted position (FIG. 7), the placement funnel 118 is seated on the hub 136 and is in contact with the hub 136 at the contact point 180. Similarly, in the intermediate tubular member 110, the rear end position (FIG. 7) in which the proximal end portion (hub portion 136 and the like) of the distal end side holding portion 108 is seated in the outer tubular member lumen 150, and the distal end side holding portion 108. The proximal end portion (such as the hub portion 136) can be moved between the expanded position (FIG. 8) in which the proximal end portion (hub portion 136, etc.) extends distally of the outer tubular member lumen 150.

FIG. 8 clearly shows the fluid path for flushing the delivery device 100 during a medical procedure. For example, the arrow 150a indicates a state in which the fluid flows outside the outer tubular member lumen 150 and the distal end side holding portion 108. An arrow 152 a indicates a state in which the fluid flows through the inner tubular member lumen 152 into the distal side holding portion 108. The arrow 154a indicates the state in which the fluid flows through the inner tubular member lumen 154 and into the distal side holding portion 108. From a comparison of FIGS. 7 and 8, it can be seen that regardless of the position of the inner tubular member 116 (and thus the placement funnel 118) relative to the intermediate tubular member 110, fluid flows as indicated by arrow 154a. In some examples, it is desirable to be able to flow fluid through the intermediate tubular member lumen 152 and/or the outer tubular member lumen 150 even when the components are arranged as shown in FIG. .. However, in the retracted position of FIG. 7, the hub portion 136 may block fluid flow through the outer tubular member lumen 150 because the hub portion 136 is in contact with the distal end of the outer tubular member 102. In some examples, the hub portion 136 has one or more fluid flow channels (grooves and/or openings) that are arranged in alignment with the outer tubular member lumen 150. The flow path allows fluid to flow through the outer tubular member lumen 150.

Similarly, the placement funnel 118 seated on the hub portion 136 has an intermediate tubular shape except for the fluid path formed between the interface between the placement funnel 118 and the hub portion 136 of the distal side holding portion 108. There is a possibility of blocking the flow of fluid from the member lumen 152 into the distal-side holding portion 108. In some examples, placement funnel 118 has one or more fluid pathways 119 formed through or along placement funnel 118. As indicated by arrow 181, the fluid passes through the intermediate tubular member lumen 152 and into the distal holder 108 via the fluid path 119. Therefore, the flow of the fluid is not obstructed by the hub portion 136, and the fluid can flow beyond the contact point 180 between the funnel 118 and the hub portion 136. The fluid path 119 may be one or more openings extending through the placement funnel 118 or channels such as grooves or recesses formed in the outer surface of the placement funnel 118.

9A-14 illustrate exemplary and non-limiting examples of deployment funnels having exemplary fluid paths. These placement funnels have a fluid path to allow fluid flow from the intermediate tubular member lumen 152 and/or the inner tubular member lumen 154 past the placement funnel and into the distal retention portion 108. enable. Accordingly, before and during use of the delivery device 100, the placement funnel is seated on the hub 136 of the distal-side holding portion 108, or the head portion 32 of the docking member 30 is seated on the placement funnel 118. In the state, fluid cleaning can be performed. 9A-14 illustrate some structural modifications to the placement funnel 118, with some modifications being made to one or more tubular members. In some examples, fluid flow is enabled by modifying the hub portion 136 itself, rather than modifying the placement funnel 118. For example, a groove or flow path is formed in the tip portion 137 of the hub portion 136 to allow the flow of fluid through the placement funnel 118.

FIG. 9A is an end view showing the placement funnel 218 having an annular cross-sectional shape at least at the outer periphery 220 of the placement funnel 218. 9B is a cross-sectional view of the placement funnel 218 taken along line 9B-9B of FIG. 9A. Inner tubular member lumen 154 is shown extending through the center of deployment funnel 218. In some examples, the placement funnel 218 has one or more channels that extend, for example, through a wall of the placement funnel 218 (eg, axially through). One or more openings 222 that are present. Since the fluid can flow through the opening 222, the fluid can flow past the placement funnel 218 and into the distal-side holding portion 108 (FIG. 8 ). The opening 222 may be mechanically formed in the placement funnel 218, for example, the opening 222 extending from the proximal end surface of the placement funnel 218 to the distal end surface of the placement funnel 218 may extend through the wall of the placement funnel 218. It may be perforated. In some examples, laser cutting forms opening 222.

Although a total of four openings 222 are shown that are evenly spaced along the perimeter 220, in another example, five, six or more separate openings 222 are formed in the placement funnel 218. To be done. In some other examples, the placement funnel 218 has one, two, or three separate openings 222. Although the openings 222 are shown as generally circular, in some examples one or more openings 222 may have any desired shape. For example, one or more of the openings 222 may be elliptical or polygonal. In some examples, the one or more openings 222 are elongated. For example, the deployment funnel 218 may include a first elongate slot 224 and a second elongate slot 226, each slot extending between a pair of openings 222. In some examples, the placement funnel 218 has additional elongated slots as needed. Configurations other than these examples are possible.

FIG. 10 illustrates outer tubular member 102, intermediate tubular member 110, and inner tubular member 116 having configurations that can be used to position implantable device 10. As described in connection with FIG. 4, the tether 112 extends distally through the inner tubular member lumen 154 and the deployment funnel 318 and is coupled to the tether retaining structure 36. For example, as shown in FIG. 10, the tether 112 extends through the opening 38, around the tether retaining structure 36, and returns proximally through the inner tubular member lumen 154. The tether 112 does not impede fluid flow through the inner tubular member lumen 154.

In FIG. 10, the deployment funnel 318 is attached to the distal end of the inner tubular member 116 and the inner tubular member lumen 154 extends through the central opening of the deployment funnel 318, as described below in connection with FIG. 11A. There is. The placement funnel 318 replaces the opening 222 (FIGS. 9A and 9B) forming the fluid path 119 with one or more recesses or grooves 332 (shown in the figure) formed in the radially outer surface 330 of the flared portion of the placement funnel 318. 11A). That is, the radially outer surface 330 of the placement funnel 318 forms a grooved outer periphery. FIG. 11A is an end view of a placement funnel 318 having a grooved perimeter 320. FIG. 11B is a perspective view of this placement funnel 318. Inner tubular member lumen 154 is shown extending through the center of deployment funnel 318. In some examples, the grooved outer perimeter 320 has one or more recesses or grooves 332 formed in the outer surface 330 of the placement funnel 318, such as by molding. The outer surface 330 is the surface of the placement funnel 318 facing the proximal end, and a portion of the outer surface 330 contacts and/or seats the surface of the hub portion 136 at the contact point 180. For example, when the protruding portion of the grooved outer peripheral portion 320 located between the concave portions or the grooves 332 is seated on the surface of the hub portion 136, the surface of the hub portion 136 (shown by a broken line) and the concave portion Alternatively, a fluid path is formed with the surface of the funnel 318 forming the groove 332. In some examples, the outer periphery of the placement funnel 318 is annular and the recess 330 or groove 332 is machined into the outer surface 330 of the placement funnel 318. The recess or groove 332 allows fluid to flow, for example, from the intermediate tubular member lumen 152 past the deployment funnel 318, which causes fluid to flow to the distal retention portion 108 (FIG. 8). The placement funnel 318 has one or more recesses or grooves 332. Although a total of four recesses or grooves 332 are shown that are evenly spaced along the perimeter 320, in another example, five, six or more separate recesses or grooves 332 are disposed in the funnel 318. Is formed. In some other examples, the placement funnel 318 has one, two, or three separate recesses or grooves 332.

FIG. 11C is a perspective view of a deployment funnel 318a having a grooved outer periphery 320a that includes one or more recesses or grooves 332a. The recess or groove 332a is formed in the placement funnel 318a by molding or the like. FIG. 11D is an end view of the placement funnel 318a. In some examples, the provision of the recess or groove 332a when the portion of the deployment funnel 318a between the recesses or grooves 332a contacts or seats the surface of the hub portion 136 at the contact point 180, thereby providing the hub A fluid path is formed between the surface of section 136 (shown in phantom) and the surface of placement funnel 318a forming groove 332a. In some examples, the outer perimeter of the placement funnel 318a is annular and the groove 332a is machined into the outer surface of the placement funnel 318a. The groove 332a allows fluid to flow, for example, from the intermediate tubular member lumen 152 past the deployment funnel 318a, which causes the fluid to flow to the distal retainer 108 (FIG. 8). Although a total of four grooves 332a are shown that are evenly spaced along the perimeter 320a, in another example, five, six or more separate grooves 332a are formed in the placement funnel 318a. .. In some other examples, the placement funnel 318a has one, two, or three separate grooves 332a.

In some examples, the presence of the implantable device 10 within the distal retainer 108 (FIG. 2) causes the inner tubular member lumen 154 to pass through the deployment funnel 318a and into the distal retainer 108. The moving fluid flow can be affected. In some examples, as shown, the placement funnel 318a has one or more recesses or grooves, such as curved notches 350, formed in the radially inner surface of the flared portion of the placement funnel 318a. ing. This facilitates the flow of fluid from the inner tubular member lumen 154 through the deployment funnel 318a and beyond the head portion 32 of the docking member 30 of the implantable device 10 and into the distal retention portion 108. In some examples, each of the one or more recesses, grooves, or notches 350 is a curved notch having a radial extension 352 and an axial extension 354. Is considered FIG. 11E shows the implantable device 10 with the head portion 32 of the docking member 30 seated on the radially inner surface of the flared portion of the deployment funnel 318a (which occurs inside the distal holding portion 108). As shown, the radial extension 352 of each of the one or more curved cutouts 350 includes an outer periphery of the head portion 32 of the docking member 30 extending proximally from the implantable device 10. To the outside in the radial direction. One or more recesses, grooves or notches 350 are formed on the radial inner surface of the placement funnel 318a, one or more between the radial inner surface of the placement funnel 318a and the surface of the head portion 32 of the docking member 30. A plurality of fluid paths are formed. Although a total of four equally spaced recesses, grooves or cutouts 350 are shown, in another example, five, six or more separate recesses, grooves or cutouts 350 are placed. It is formed on the funnel 318a. In some other examples, the placement funnel 318a has one, two or three separate recesses, grooves or notches 350.

FIG. 12 is a partial cross-sectional view showing an outer tubular member 102, an intermediate tubular member 110, and an inner tubular member 116 that can be used to position the implantable device 10. 4, the tether 112 extends distally through the inner tubular member lumen 154 and the deployment funnel 118 and is coupled to the tether retaining structure 36. For example, as shown in FIG. 12, the tether 112 extends through the opening 38, around the tether retention structure 36, and returns proximally through the inner tubular member lumen 154. The tether 112 does not impede fluid flow through the inner tubular member lumen 154.

The placement funnel 118 shown in FIG. 12 does not include features that allow fluid flow through the contact points 180. In some examples, the placement funnel 118 may have one or more openings, grooves or other structures that allow fluid flow through the contact points 180. In some examples, the intermediate tubular member 110 has one or more openings 190. The opening 190 allows fluid flowing within the outer tubular member lumen 150 from the outer tubular member lumen 150 through the one or more openings 190 into the intermediate tubular member lumen 152, as indicated by arrow 181. Flow into. The opening 190 may extend through the annular sidewall of the intermediate tubular member 110. Alternatively, the opening may be formed at a joint of the intermediate tubular member 110, such as a joint between the intermediate tubular member 110 and the hub portion 136. In some examples, inner tubular member 116 has one or more openings 192. The opening 192 allows the fluid flowing within the intermediate tubular member lumen 152 to flow into the inner tubular member lumen 154 through one or more openings 192, as indicated by arrow 181. The opening 192 may extend through the annular sidewall of the inner tubular member 116. Alternatively, the opening may be formed at a joint of the inner tubular member 116, such as a joint between the inner tubular member 116 and the placement funnel 118. As a result, fluid flowing through the outer tubular member lumen 150 and/or fluid flowing through the intermediate tubular member lumen 152 enters the inner tubular member lumen 154 located proximal to the distal retainer 108. , Around the head portion 32 of the docking member 30, passes through the arrangement funnel 118, flows toward the tip side, and enters the tip side holding portion 108. In this manner, the outer tubular member lumen 150 and/or the intermediate tubular member lumen 152 flow from the proximal end of the delivery device 100 (eg, one or more fluid ports in the handle assembly 120) (physiology). Washed with saline). The fluid passes through the inside of the placement funnel 118 and is discharged into the distal-side holding portion 108.

FIG. 13 is a side view of a deployment funnel 418 having an outer surface 430. In some examples, the outer surface 430 is formed with a spiral groove 432. The illustrated spiral groove 432 has a total of three turns, but in some examples, the spiral groove 432 has a relatively narrow pitch and surrounds the placement funnel 418. More than three windings are arranged. In some examples, the pitch (and thus the number of turns) correlates with the relative width and/or depth of spiral groove 418. For example, if the pitch is relatively large (the pitch shown), then the width and/or depth of the spiral groove 418 may be made relatively large to accommodate the fluid flow. Alternatively, when the pitch is narrower and the number of winding portions is large, a sufficient number of flow paths are formed so that the fluid can pass through the arrangement funnel 418 and flow into the distal-side holding portion 108, and thus the spiral groove is formed. The width and/or depth of 418 may be small. The spiral groove 432 may be either a left-handed spiral or a right-handed spiral.

9A, 9B, 11A, 11B, 11C, 11D, 11E, 12 and 13 show examples of placement funnels with structures for promoting fluid flow through the placement funnels. In some examples, the placement funnel itself is configured to allow fluid to flow through the placement funnel. For example, in some examples the placement funnel is formed of a porous material. In some examples, the placement funnel is a polymeric structure having a plurality of microchannels, holes, etc. formed therein to allow fluid flow. In some examples, the placement funnel is formed of open cell foam. In some examples, the placement funnel is formed of bonded fibers. The placement funnel may be formed of, for example, a woven or non-woven material.

FIG. 14 shows an example of an arrangement funnel 518 having a lattice structure or a mesh structure. FIG. 14 shows a placement funnel 518 that is braided. The arrangement funnel 518 includes a plurality of first winding portions 540 spirally extending in the first direction and a plurality of second winding portions 542 spirally extending in a second direction different from the first direction. Have The plurality of first winding portions 540 intersect the second winding portion 542 at the plurality of intersections 544. In some examples, the intersections 544 are relatively closely spaced from each other and the gap 546 surrounded by the turns 540 and the turns 542 is relatively small. In some examples, the intersections 544 are relatively widely spaced from one another and the gap 546 surrounded by the turns 540 and the turns 542 is relatively large. This dimension can be set to take into account the desired mechanical strength of the placement funnel 518 and the desired flow of fluid through the placement funnel 518.

Various components of delivery device 100 (and/or other delivery structures disclosed herein) and materials that can be used for the various components disclosed herein include those commonly used in medical devices. The materials used may be mentioned. For ease of explanation, the following description is provided in connection with delivery device 100, but this is not intended to limit the devices and methods described herein, and the following description , Other similar delivery systems and/or components of delivery systems or other described devices.

In some embodiments, the delivery device 100 and/or components of the delivery device are metals, metal alloys, polymers (examples of which are listed below), metal-polymer compositions, ceramics, combinations thereof or other suitable. It is made of various materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). DELRIN®, polyether block ester, polyurethane (eg polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (eg from DSM Engineering Plastics). Possible ARNITEL), ether- or ester-based copolymers (eg butylene/poly(alkylene ether) phthalates and/or other polyester elastomers such as HYTREL® available from DuPont), polyamides (For example DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastic polyamides, block polyamide/ethers, polyether block amides (PEBAs, eg Available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (eg REXELL). (Registered trademark)), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide ( PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (eg KEVLAR®), polysulfone, nylon, nylon 12 (GRILAMID available from EMS American Grilon). (Registered trademark), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-su). Ethylene) (eg SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures thereof, combinations thereof, copolymers thereof, polymer/metal composites and the like. .. In some embodiments, the sheath is mixed with a liquid crystal polymer (LCP). For example, the mixture contains up to about 6% LCP.

Some examples of suitable metals and alloys include stainless steels such as 304V, 304L and 316LV stainless steels, mild steels, nickel-titanium alloys such as linear elastic and/or superelastic nitinol, other nickel alloys such as , Nickel-chromium-molybdenum alloy (for example, UNCON: N06625 such as INCONEL (registered trademark) 625, UNS: N06022 such as HASTELLOY (registered trademark) C-22 (registered trademark), HASTELLOY (registered trademark) C276 (registered trademark)) Such as UNS:N10276, other HASTELLOY (registered trademark) alloys, nickel-copper alloy (MONEL (registered trademark) 400, NICKELVAC (registered trademark) 400, NICORROS (registered trademark) 400 and other UNS:N04400), nickel- Cobalt-chromium-molybdenum alloy (for example, UNS:R30035 such as MP35-N (registered trademark)), nickel-molybdenum alloy (UNS:N10665 such as HASTELLOY (registered trademark) ALLOY B2 (registered trademark)), other nickel- Chromium alloy, other nickel-molybdenum alloy, other nickel-cobalt alloy, other nickel-iron alloy, other nickel-copper alloy, other nickel-tungsten or other nickel alloy such as tungsten alloy, cobalt-chromium alloy, Cobalt-chromium-molybdenum alloys (e.g. ELGILOY(R), PHYNOX(R), etc. UNS:R30003), platinum enriched stainless steel, titanium, combinations thereof or other suitable materials may be mentioned.

In at least some embodiments, some or all of the delivery device 100 and/or components of the delivery system are doped with, formed from, a radiopaque material, or other The method comprises a radiopaque material. Radiopaque materials are materials that are capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image helps the user to locate delivery device 100. Examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Also, other radiopaque marker bands and/or coils can be incorporated into the design of delivery device 100 to achieve the same result.

It should be understood that this disclosure is, in many respects, merely exemplary. Changes may be made in details, particularly in matters of shape, size and arrangement of steps without exceeding the scope of the invention. This includes the use of any feature of one exemplary embodiment in another, to the extent appropriate. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims (15)

A delivery device for delivering an implantable leadless pacing device, comprising:
An outer tubular member having an outer tubular member lumen extending from a proximal end thereof to a distal end thereof;
An intermediate tubular member that is coaxially and slidably disposed in the outer tubular member lumen and that extends from the proximal end to the distal end of the intermediate tubular member lumen; An intermediate tubular member,
An inner tubular member coaxially and slidably arranged with the inner tubular member lumen, the inner tubular member lumen extending from a proximal end to a distal end thereof; An inner tubular member that is
A distal side holding portion that extends from the distal end of the intermediate tubular member to the distal side, and has a void formed therein to receive the implantable leadless pacing device,
An arrangement funnel fixed to the tip of the inner tubular member, wherein the arrangement funnel extends to the tip side in the tip side holding portion, and an arrangement funnel is in the base end portion of the tip side holding portion. A placement funnel that is movable between a retracted position seated at
The delivery device, wherein the deployment funnel is configured to allow fluid flow from the tip of the intermediate tubular member lumen into the distal retention portion when the deployment funnel is in the retracted position. The placement funnel has one or more openings penetrating through the placement funnel and in communication with the intermediate tubular member lumen, whereby the tip of the intermediate tubular member lumen extends from the distal end of the intermediate tubular member lumen. The delivery device of claim 1, wherein fluid is allowed to flow into the distal retainer through one or more openings. The deployment funnel has one or more grooves in communication with the intermediate tubular member lumen, thereby allowing fluid to flow from the tip of the intermediate tubular member lumen through the one or more grooves. The delivery device according to claim 1, wherein the delivery device can flow into the distal-side holding portion. 2. The delivery device of claim 1, wherein at least a portion of the deployment funnel comprises a porous material, allowing fluid to flow through the pores of the porous material. 2. The delivery device of claim 1, wherein at least a portion of the deployment funnel comprises scaffolding material to allow fluid to flow through the gaps in the scaffolding material. Any of claims 1-5, wherein the deployment funnel is further configured to provide a fluidic connection between the inner tubular member lumen and the distal retainer when the deployment funnel is in the retracted position. The delivery device according to claim 1. A delivery device for delivering an implantable leadless pacing device, comprising:
An outer tubular member forming an outer tubular member lumen extending from a proximal end thereof to a distal end thereof;
An intermediate tubular member that is movably disposed within the outer tubular member lumen and that forms an intermediate tubular member lumen extending from a proximal end to a distal end of the intermediate tubular member; ,
A distal side holding portion that extends from the distal end of the intermediate tubular member to the distal side and is configured to accommodate at least a part of the implantable leadless pacing device,
An inner tubular member movably disposed within the inner tubular member lumen and forming an inner tubular member lumen extending from a proximal end to a distal end of the inner tubular member; ,
A placement funnel fixed to the tip of the inner tubular member,
The intermediate tubular member has a retracted position in which the proximal end portion of the distal-side holding portion is seated in the outer tubular member lumen, and the proximal end portion of the distal-side holding portion extends from the outer tubular member lumen toward the distal side. Is movable to and from the extended position
The inner tubular member is movable between an expanded position in which the placement funnel extends distally within the distal side retainer and a retracted position in which the placement funnel is seated within the proximal end of the distal side retainer. Yes,
The delivery device, wherein the deployment funnel is configured to allow fluid to flow from the tip of the lumen of the intermediate tubular member into the distal retention portion when in the retracted position. One or more openings through the placement funnel or one or more on the surface of the placement funnel to allow fluid to flow past the placement funnel in the retracted position. 8. The delivery device of claim 7, having a groove. The inner tubular member has an opening on the proximal side of the distal end of the inner tubular member, and the opening forms a fluid path between the inner tubular member lumen and the inner tubular member lumen. Wherein the fluid is allowed to enter the inner tubular member lumen from the intermediate tubular member lumen, flow distally through the placement funnel and into the distal retainer. Or the delivery device according to 8. The intermediate tubular member has an opening at the base end side of the distal end of the intermediate tubular member, and the opening forms a fluid path between the outer tubular member lumen and the intermediate tubular member lumen. 10. As a result, the fluid can enter the inner tubular member lumen from the outer tubular member lumen, flow toward the distal end side, and flow into the distal end side holding portion. The delivery device according to paragraph 1. A delivery system for delivering a leadless cardiac pacemaker (LCP), comprising:
A flexible shaft forming a flexible shaft lumen,
An expansion shaft extending through the flexible shaft lumen and forming an expansion shaft lumen;
A leadless cardiac pacemaker sleeve fixed to and extending distally from the tip of the expansion shaft and configured to at least partially contain a leadless cardiac pacemaker for delivery.
A deployment shaft extending through the expansion shaft lumen to form a deployment shaft lumen;
Fixed to the distal end of the deployment shaft, the leadless heart pacemaker sleeve holds the leadless heart pacemaker in place when the leadless heart pacemaker sleeve is withdrawn proximally relative to the leadless heart pacemaker. A placement funnel configured to engage a pacemaker,
The deployment funnel is configured to receive a tether extending through the deployment shaft lumen and through a central opening of the deployment funnel,
The central opening is aligned with the deployment shaft lumen,
The deployment funnel has one or more fluid structures that allow fluid to flow distally from the expansion shaft lumen past the deployment funnel and into the leadless cardiac pacemaker sleeve. system. 12. The deployment funnel has one or more grooves in the surface of the deployment funnel to allow fluid to pass through the deployment funnel and into the leadless cardiac pacemaker sleeve. The delivery system according to. 13. The delivery system of claim 12, wherein the one or more grooves are formed in a radially outer surface of the deployment funnel that seats on a hub portion of the leadless cardiac pacemaker sleeve. 13. The delivery system of claim 12, wherein the one or more grooves are formed in a radially inner surface of the deployment funnel that seats on a head portion of a docking member of the leadless cardiac pacemaker. The deployment shaft has an opening extending through the sidewall, the opening defining a fluid path between the expansion shaft lumen and the deployment shaft lumen. 15. A fluid according to any of claims 11-14, wherein fluid is allowed to enter the deployment shaft lumen from the expansion shaft lumen, flow distally through the deployment funnel and into the leadless cardiac pacemaker sleeve. The delivery system according to paragraph 1.

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